Quality Assurance

Christine Summers

acy4u1@r.postjobfree.com 847-***-**** 510 W Eastman Street Arlington Heights, Illinois 60005

Influential leadership and supervisory abilities; able to coordinate and oversee cross-functional teams, fostering highly productive and results-focused team environments.

Highly effective at producing departmental policies and procedures, performing change/configuration management, and process, budget and schedule coordination.

Dynamic communications skills, with success developing and maintaining lasting relationships with key participants, while fully communicating with clients and executives at all levels of technical proficiency.

Coordinate documentation, manuals and training materials, leveraging outstanding organizational and analytical skills with attention to detail, analyzing and revising processes and improving accuracy and efficiency.

Proficient in Microsoft Office Suite, Lotus Notes, TrackWise, Documentum, Adobe Acrobat, Qumas, Prism Inventory System, Blue Mountain Calibration.

Professional Experience

Kohl's – Arlington Heights, Illinois (Part-time) 11/2016 to Current Seasonal Freight Associate

Unloading trucks to organizing and restocking merchandise to sales floor.

Panera Bread – Arlington Heights, Illinois (Part-time) 09/2016 to 12/2016 Panera Bread Bakery -Cafe Associate

Delivered fast friendly service through direct customer interaction as a cashier.

Provided quality assurance inspection to daily operations ensuring oven and bread slicers met SOP standards.

Levy's Restaurants – Arlington Heights, Illinois Part-time ending 09/25/16 04/2016 to 09/2016

Concessions Cashier - Cobey's Food Court

Concession operations at Arlington Heights Race Track

Home depot – Elk Grove Village, Illinois 12/2008 to 03/2015

Merchandising Execution Associate

Merchandised and maintained products sets to enhance customer experience, increase sales, and maximize inventory turns. Communicated with vendors to ensure bays sets were compliant with SOP's.

Arranged displays; ordered label materials, signage and brochures.

Awarded with the "Homer Award" having the best Millwork department vendor displays and brochure set up in the state region from the vendor.

Saved 100k and increased productivity by 20% in one store by training new on-board team associates to meet a higher level of quality and more efficient standards in bay service inspection.

Home Depot – Elk Grove Village, Illinois 11/2006 to 12/2008

Inventory Management Associate

Maintained inventory levels to meet customer, seasonal, and promotional needs.

Identified and resolve freight flow issues with vendors. Prioritized daily, weekly, and monthly responsibilities.

Understanding reports used to accomplish these levels including seasonality, Turns, Gmroi, Stat planner.

Dentsply Pharmaceuticals – Elk Grove Village, Illinois 03/2005 to 03/2006

Batch Control Coordinator / Documentation Control

Performed review of batch records required for product release. Including note book studies (NES), process validation (PV), stability and media fill batch documents.

Reviewed incident/deviation reports, QC and Microbiology testing results. Issued electronic batch records.

Coordinated SOP review, revision and change control system.

Pfizer Corporation – Mt. Prospect, Illinois 01/2000 to 04/2004

Pharmacia (Formerly Searle, a Monsanto Life Science Company)

Quality Assurance Specialist

Facilitated cleaning validation tracking to update and validate master plan and support QA manager with review of IQ/OQ qualifications and cleaning validations protocols.

Coordinated, sampled chemical, microbial plating, Air, Surface and detergent residue testing.

Supported pilot plant Purified Water System for performance qualification/validation.

Responsible for calibration activity tracking and calibration of QA physical inspection equipment.

Reviewed NDA documentation for PAI readiness. Participated in corporate internal GMP audit program.

Obtained QA Sampler responsibilities while taking over Specialist tasks previously performed by two former QA specialists, ensuring that priorities were met; made positive impact on relationship between QA and Analytical Services/Pharm Tech departments.

Developed spreadsheets for database to track Elk Grove low temperature storage monitoring.

Searle/Monsanto – Mt. Prospect, Illinois 11/1998 to 01/2000

Quality Assurance Sampler

Responsible for sampling, inspection, testing sample submission, documentation review, and final disposition of pharmaceutical products and raw materials. Provided line support for clinical/stability batch production.

Reviewed contract/third party component records and supported QA activities for launch of Searle/Pfizer Celebrex (celecoxib 2) capsules. Prepared and approved QA master label pages.

Pharmaceuticals – Franklin Park / Elk Grove, Illinois 08/1982 to 11/1997

Research & Development Laboratory Assistant (1994 to 1997)

Assisted formulation scientist in pre-formulation/formulation of parenteral solutions. Coordinated stability program for ANDA batch studies and sample pull testing. Reviewed and maintained raw material inventory and CofA, MSDS and SOP documents.

QC Stability Retention Warehouse Coordinator (1990 to 1994)

Supervised and trained warehouse assistants in storage, analytical testing sampling, visual stability/customer complaint inspections and disposition of manufactured products at offsite warehouse facility.

Documentation Specialist (1987 to 1990)

Responsible for product annual review. Reviewed and approved product batch records for commercial Distribution. Assigned, tracked and distribute SOPs.

QA Lead Person (1984 to 1987)

Trained QA Technicians at newly opened facility. Lead technicians in the day-to-day aseptic manufacturing operations to ensure cGMP compliance.

Quality Assurance Technician (1982 to 1984)

Monitored and documented operations during manufacturing and packaging process, in-process and final finished product sample testing. Inspected returned goods. performed air and surface testing and Sterility and LAL testing o the Microbiology Department.

Education & Training

Robert Morris University, Chicago, Illinois

Completed credits towards Business Management Administration Degree.

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